Custom thermoplastic versus factory-made thumb orthoses for boutonniere deformity
Boutonniere Deformity Effectiveness of Thermoplastic and Fabricated Orthoses
This test will see if a custom thermoplastic thumb orthosis helps women aged 18–65 with rheumatoid arthritis-related boutonniere deformity improve hand strength, dexterity, and pain compared with factory-made orthoses.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Józef Piłsudski University of Physical Education Academic / other |
| Locations | 2 sites (Warsaw, Masovian Voivodeship and 1 other locations) |
| Trial ID | NCT06267469 on ClinicalTrials.gov |
What this trial studies
About 60 participants (approximately 30 using custom thermoplastic orthoses and 30 using factory-made orthoses) will be enrolled to compare outcomes. Hand grip and pincer strength will be measured with a dynamometer, and dexterity and pain scores will be recorded with and without the orthosis at baseline and at scheduled follow-ups. The protocol focuses on female patients aged 18–65 with rheumatoid arthritis and type I or II boutonniere thumb deformity meeting the study timing restrictions for prior surgery and injections. The primary comparisons are change in dexterity, whole-hand and pincer grip strength, and pain between the two orthosis groups.
Who should consider this trial
Good fit: Women aged 18–65 with rheumatoid arthritis and a diagnosed type I or II boutonniere thumb deformity who consent and meet the required timing since surgery/injections are the intended participants.
Not a fit: Men, people with other thumb deformities, those less than one year after hand surgery, within six months of a thumb injection, or who change treatment during the study are excluded and unlikely to gain from this comparison.
Why it matters
Potential benefit: If successful, the custom thermoplastic orthosis could improve grip and pinch strength, dexterity, and reduce pain more than factory-made orthoses.
How similar studies have performed: Custom thermoplastic splints are commonly used for hand deformities and small case series suggest benefit, but high-quality comparative data specific to rheumatoid boutonniere thumb deformity are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * diagnosed with RA * diagnosed thumb deformity: butonier finger, type I or II * female * age 18 - 65 years * patient's consent to the study Exclusion Criteria: * other deformity of the thumb * less than 1 year since surgical intervention in the hand * less than 6 months since delivery injections within the thumb * change in treatment during the study and 3 months before the study
Where this trial is running
Warsaw, Masovian Voivodeship and 1 other locations
- Terapia Ręki Magda Kolasińska — Warsaw, Masovian Voivodeship, Poland (Recruiting)
- Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher — Warsaw, Masovian Voivodeship, Poland (Recruiting)
Study contacts
- Study coordinator: Magdalena Kolasińska, MSc
- Email: magdalena.kolasinska@awf.edu.pl
- Phone: +48609219822
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.